FDA Product Code BTM: Ventilator, Emergency, Manual (resuscitator)
Leading manufacturers include Foremount Enterprise Co., Ltd., Flexicare Medical Limited. and Xiamen Compower Medical Tech. Co., Ltd..
209
Total
209
Cleared
124d
Avg days
1976
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg
155d
recently vs 123d historically
FDA 510(k) Cleared Ventilator, Emergency, Manual (resuscitator) Devices (Product Code BTM)
209 devices
Cleared
Nov 24, 2025
The BAG manual resuscitator and accessories
Laerdal Medical AS
Anesthesiology
180d
Cleared
Apr 25, 2025
butterflyBVM
Compact Medical, Inc.
Anesthesiology
130d
Cleared
Mar 18, 2023
EOlife®
Archeon
Anesthesiology
267d
Cleared
Aug 18, 2022
Sotair Device
Safe Bvm Corporation
Anesthesiology
339d
Cleared
Aug 26, 2021
Disposable Manual Resuscitator
Xiamen Compower Medical Tech. Co., Ltd.
Anesthesiology
205d
Cleared
Dec 07, 2018
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
Flexicare Medical Limited.
Anesthesiology
175d
Cleared
May 11, 2018
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
Foremount Enterprise Co., Ltd.
Anesthesiology
431d
About Product Code BTM - Regulatory Context
510(k) Submission Activity
209 total 510(k) submissions under product code BTM since 1976, with 209 receiving FDA clearance (average review time: 124 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - BTM Product Code
Recent submissions under BTM have taken an average of 155 days to reach a decision - up from 123 days historically. Manufacturers should account for longer review timelines in current project planning.
BTM devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →